All about desiccated thyroid as a grandfathered in, yet “unapproved” drug

Why have I had a hard time fin­ding desic­ca­ted thy­roid at any phar­macy?  Was there really shor­ta­ges of natu­ral desic­ca­ted thy­roid?  Is natu­ral desic­ca­ted thy­roid being ban­ned? What hap­pe­ned to Armour by Forest Labs? What about Naturethroid?

And where is the FDA in all this?

Below is a his­tory of the use and pro­duc­tion of desic­ca­ted thy­roid that may help ans­wer your questions.

Natu­ral desic­ca­ted thy­roid is a treat­ment that had its first medi­cally docu­men­ted use in 1891, and suc­cess­fully.  The details of this first and sub­se­quent uses start of page 39 of the Stop the Thy­roid Mad­ness book.   It rose in popu­la­rity and was deter­mi­ned quickly to be a great treat­ment for hypothy­roi­dism. “Armour” was one of seve­ral brands.

In 1906 came the begin­ning of the FDA’s current regu­la­tions with the pas­sage of the Pure Food and Drugs Act. This act was crea­ted to pre­vent the com­merce of “adul­te­ra­ted and mis­bran­ded food and drugs”.

In 1938 came the Food, Drug and Cos­me­tic Act which gave the FDA autho­rity to over­see the safety of all three of the lat­ter. Many medi­ca­tions already in use, like Armour and Natu­reth­roid,  were “grand­fathe­red in”.

In the early 1960’s came the Drug Effi­cacy Study Imple­men­ta­tion (DESI) by the FDA which was meant to clas­sify drugs intro­du­ced bet­ween 1938 and 1962 as either effec­tive, inef­fec­tive, or nee­ding further study. That study was com­ple­ted in 1969.

Then came 2006 and a new Com­pliance Policy Guide (CPG, upda­ted June 20^th of 2006) which tar­gets the remai­ning unap­pro­ved drugs like natu­ral desic­ca­ted thy­roid and which ulti­ma­tely requi­res the phar­ma­ceu­ti­cals which make these drugs to “prove” their effec­ti­ve­ness and safety (i.e. 110 years of millions of safe and effec­tive use of desic­ca­ted thy­roid by patients is not enough for the FDA, it appears). The proof comes in an NDA (New Drug Appli­ca­tion) and rigo­rous cli­ni­cal trials, which are quite expensive.

An impor­tant sen­tence in the CPG is found in Sec­tion II A: We want to achieve these goals without adver­sely affec­ting public health, impo­sing undue bur­dens on con­su­mers, or unne­ces­sa­rily dis­rup­ting the mar­ket. In other words, all thy­roid patients who know the supe­rio­rity of desic­ca­ted thy­roid will be kee­ping the FDA to task for this.

All the above led to 2009, where in April, patients saw the FDA act upon the com­pliance by infor­ming two gene­ric makers to cease pro­duc­tion, since they star­ted long after.  Time Caps Labs was war­ned in April  (scroll down about 3/4^th to the hea­ding Unap­pro­ved New Presc­rip­tion Drugs). There is no FDA-listed war­ning for Major Phar­ma­ceu­ti­cals, the other gene­ric maker, but they cea­sed as well.

Also in early 2009, Forest Labs refor­mu­la­ted the long popu­lar and effec­tive Armour desic­ca­ted thy­roid, sup­po­sedly rai­sing the cellu­lose and lowe­ring the suc­rose. Patients were no lon­ger able to do Armour sublin­gually, and they repor­ted a return of hypothy­roid symp­toms and new strange ones.  So most made a sad exo­dus from the use of Armour to other brands.

Also in 2009, a shor­tage of US-made desic­ca­ted pow­der occu­rred, first coming from the only North Ame­ri­can manu­fac­tu­rer of the pow­der: Ame­ri­can Labs.  The sta­ted cause was demand being grea­ter than supply – an actual pos­si­bi­lity since web­si­tes like STTM and patients groups were espou­sing how well it works, so many patients were switching.

By Fall of 2009, The FDA appro­ved US presc­rip­tions to be used at Cana­dian Phar­ma­cies for Erfa’s “Thy­roid”.  Com­poun­ding desic­ca­ted thy­roid also found more busi­ness in the US.

January 2010 saw RLC Labs, the makers of Natu­reth­roid, begin­ning to send out sup­plies of their brand. The same star­ted to be true with the newly for­mu­la­ted Armour by February (but most patients yaw­ned about that, since the Armour now suc­ked for many.)

By February 2010, it became clear that Natu­reth­roid had also been refor­mu­la­ted, even if dife­rently. RLC sta­ted that they chan­ged the cellu­lose from methyl to micro as an impro­ve­ment, and they remo­ved potas­sium from the tablet. Infor­ma­tion is con­fu­sing as to what really chan­ged, since RLC became more pri­vate in their com­mu­ni­ca­tions with patients — an attor­ney mandate.

Read the Options for Thy­roid Treat­ment to see all your possibilities.